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Active, Not Recruiting

NCT Number: NCT06400082

Topical Insulin for Postoperative Wound Healing

This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Wound Complication Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Resistance, Diabetes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Omnia Azmy Nabeh

Cairo, 11562, Egypt

About this study

The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both males and females
  • 40-60 years old
  • diagnosed with type 2 DM (for the diabetic trial)
  • For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 %
  • haemoglobin (Hb) ≥ 12 g/dl
  • Patients who had a full thickness post-operative wound of ≥10 cm

Exclusion criteria

  • Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion.
  • Patients who had hypersensitivity to insulin,
  • Patients with severe infection,
  • Patients with any severe organ dysfunction
  • Patients who were admitted to ICU

Treatment and study plan

Insulin

Drug

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Povidone-Iodine

Drug

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Primary outcomes

  1. Calculation of Unit Healing Time index

    Time frame: Before and after 7 days of therapy

    The total healing days and the surface area of the wound will be combined to report unit healing time in units

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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